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Jefferies Global Healthcare
Conference
June 2013
COPYRIGHT 2013 by TherapeuticsMD
This presentation includes forward-looking statements covered by the safe harbor provision of the
Private Securities Litigation Reform Act of 1995, including predictions, estimates, and other
information that might be considered forward-looking. While these forward-looking statements
represent TherapeuticsMD, Inc.’s (“TherapeuticsMD,” “we,” “us,” and “our”) current judgment on
what the future holds, they are subject to risks and uncertainties, many of which are outside our
control, that could cause actual results to differ materially from the results discussed in the forward-
looking statements.
You are cautioned not to place undue reliance on these forward-looking statements, which reflect
our opinions only as of the date of this presentation. Please keep in mind that we are not obligating
ourselves to revise or publicly release the results of any revision to these forward-looking
statements in light of new information, future events, or otherwise.
Throughout this presentation, we will attempt to present some important factors relating to our
business that may affect our predictions. You should also review our most recent Form 10-K and our
other filings with the Securities and Exchange Commission, for a more complete discussion of these
factors and other risks, particularly under the heading “Risk Factors.” A PDF copy of our SEC filings,
press releases and financial tables can be viewed and downloaded on the TherapeuticsMD website:
www.therapeuticsmd.com/InvestorRelations.aspx.
1
Forward-Looking Statements
Company Overview
2
3
TXMD Company History
Founded in May of 2008
Originally a prenatal vitamin company
Recently listed on NYSE MKT under “TXMD”
Shares outstanding: approximately 130 million
Approximately $40 million in cash; no long-term debt
Strong board with blue-chip institutional holders
Gov. Tommy Thompson, Jules Musing, Ernest Mario (investor)
2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2)
Combination:
17β Estradiol + Progesterone
$2,000
Oral Progesterone $300
Novel estradiol pipeline product in development
17β Estradiol in VagiCap™ $800
Phase 3 Plan Expect to File NDA and PDUFA
4
Innovative Women’s Healthcare Company
Two late-stage 505(b)(2) proposed hormone therapy (“HT”)
products targeting a multi-billion dollar U.S. market (1)(2)
Bioidentical combination of estradiol + progesterone and lower-dose
bioidentical progesterone
Set to begin pivotal Phase 3 clinical trials
(1) Phast Prescription Monthly by Source Healthcare Analytics.
(2) Estimates per: Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding; Tom Murry, Executive
Director of the Pharmaceutical Compounding Accreditation Board; and Wulf Utian, Consultant on Gynecology and Women¹s Health at The
Cleveland Clinic and Executive Director Emeritus and Honorary Founding President of The North American Menopause Society (“NAMS”).
5
History of Hormone Therapy
2002 Women’s Health Initiative (WHI) Study
Lower doses = lower side effect profile
Estrogen + Progestin (Prempro) arm had a 22% increase in breast cancer vs.
Estrogen alone arm
Resulting Hormone Prescribing Trends
Start with the lowest effective dose
Progesterone (bioidentical) popularity over Progestins (non-bioidentical)
Bioidentical (exact molecular structure of human Estrogen and Progesterone)
sales sky rocket
Sales of FDA approved oral
combination estrogen +
progestin products
Compounding pharmacy
sales of unapproved
estradiol + progesterone
6
 Significant demand
HT Combination Market Landscape
(1) Phast Prescription Monthly by Source Healthcare Analytics.
(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
(3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS.
(4) Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding, stated the U.S. drug compounding
market is $10-$12 billion; and Tom Murry, Executive Director of the Pharmaceutical Compounding Accreditation Board, said HT for
post-menopausal women is by far the largest of four primary segments served by the compounding industry.
(5) 134 Compounding Pharmacies Survey in 34 States

$1,500 MM (3)(4)
$468 MM (1)(2)
U.S. Sales (est.)
Average Selling
Price $46.89(5)
Average WAC
Price $185.09(3)
Side Effect (1) Bioidentical Natural Progesterone
Non-Bioidentical Progestins
(MPA, NETA, drosperinone)
Breast cancer More favorable profile (E3N-EPIC study) Increased risk
Cardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTE
Lipid profile More favorable profile (PEPI trial)
Less favorable effects on lipid profile
(cholesterol, HDL, LDL, triglycerides)
Glucose / insulin
Improved carbohydrate metabolism
(PEPI trial)
Deterioration of glucose tolerance or
hyperinsulemia or both
Sleep / mood Improved sleep efficiency (2) No benefit on sleep properties
Quality of life
Improvement in symptoms and overall satisfaction with bioidentical progesterone
HT compared to MPA regimen (3)
7
(1) Alone or in combination with estrogen.
(2) Caufriez, Anne, Rachel Leproult, Mireille L’Hermite-Bale´riau, Myriam Kerkhofs, and Georges Copinschi. "Progesterone Prevents Sleep Disturbances and Modulates GH, TSH, and
Melatonin Secretion in Postmenopausal Women." J Clin Endocrinol Metab 96.4 (2011): 614-23.
(3) Fitzpatrick, Pace, and Wiita. "Comparison of Regimens Containing Oral Micronized Progesterone or Medroxyprogesterone Acetate on Quality of Life in Postmenopausal Women: A Cross-
Sectional Survey." J Womens Health Gend Based Med 9.4 (2000): 381-87.
Bioidentical Progesterone vs. Non-Bioidentical Progestin
The Market understands the benefits of bioidentical HT
8
 Meet PK 505(b)(2) thresholds
Novel Drug Design
Combination of Estradiol
+ Progesterone
RLD = Reference Listed Drug
API = Active Pharmaceutical Ingredient
Converted (API) from solid / crystalline to a New Liquid Drug Form
Estrace (RLD) is a tablet — 0.5 mg, 1.0 mg, and 2.0 mg
Prometrium (RLD) is in suspension — 100 mg and 200 mg
New solubilized drug form
Achieves FDA requirements of uniformity and stability
Improved functional effects of API(s)
Enabling new combinations, routes, and dosages
9
Building an Extensive Patent Estate
Novel Drug Form Based Approach
Solubilized API in combination and stand-alone drug products
for HT indications
Enabling platform technology for delivery of bioidenticals to variety of
dosage forms and routes of administration (softgel oral, suppository,
transdermal, etc.)
Multi-layered Patent Strategy
Novel dosage forms, improved PK profiles (lowest effective dose,
increased bioavailability) relative to RLD, reduced side effect profile, and
formulation advancements (solvent systems, chemical stability, ratios,
ranges, and functional effects)
10
Senate HELP Bill 959 on Compounding
New England Compounding Center
Response to Meningitis outbreak, killed 50 and made over 700 patients sick
Multiple other cases of unsafe drug sales by other compounding pharmacies
Senate Bill Highlights (1)
Establishes clear FDA oversight funded by compounding pharmacy
registration fees
“Prohibits compounding of certain drug products, including those identified
by regulation as being demonstrably difficult to compound (such as complex
dosage forms and biologics), marketed FDA-approved drugs that are not in
shortage”
(1) http://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf
11
Market Forces Converge
External market changing
events
WHI
Proposed legislative
changes
Internal scientific
breakthrough
Significant shifts favor TXMD
12
Why Hormone Therapy?
HT is projected to be the largest
growth segment in the overall women’s
health drug market
Demographics driving strong growth
fundamentals
By 2015, nearly half the women in America will be
of menopausal age (1)
Women will spend more than a third of their life in
menopause and post-menopause
Very attractive commercial dynamics
Segment of the market that lacks innovation
Relatively little promotional activity in the space
Opportunity to capture market share
(1) U.S. Census Bureau.
Combination Product
13
14
Phase 3 Trial
Study: 12 month study with 12 week VMS
Sites: ~50
Subjects: 1,550
− 4 active arms (350 per arm)
− 1 placebo arm (150)
Estimated cost: $20-$25 million
Endpoints
− Vasomotor: number and severity of hot flashes (4 week and 12 weeks)
− Endometrial safety: incidence of endometrial hyperplasia (12 months)
 Conduct Phase 3 study
TX 12-001HR Combination—
Proposed Phase 3 Study

Combination of Estradiol
+ Progesterone
2012 2013E 2014E 2015E 2016E
Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16
Filed
IND
Pilot PK
Studies
Pivotal PK
Studies
NDA and PDUFA
Phase 3 Vasomotor and Endometrial Protection Study
TX 12-001HR
Combination
17β Estradiol
+
Progesterone
File IND Update &
Phase 3 Protocol
n = 62
15
95% Upper Confidence Limit for PK Parameter
Prometrium = R1
Prometrium = R2
TXMD = T
Parameter
Point Estimate
T/R Ratio
Within Subject
Std. Deviation
Upper 95%
Confidence Bound
Cmax 1.16 1.179 -0.785
AUC0-t 1.05 0.956 -0.542
Progesterone Results (1)
(1) Semilog plots of mean plasma concentrations over time for Progesterone.
TX 12-001HR Estradiol 2 mg / Progesterone 200 mg (combination)
vs. Estrace® 2 mg + Prometrium® 200 mg (separate tablets)
1
10
100
0 5 10 15 20 25 30 35 40 45 50
Time (hr)
Treatment=R1
Treatment=R2
Treatment=T
N=6217β Estradiol Results (1)
n = 62
95% Confidence Interval for PK Parameter
16
Estrace = R1
Estrace = R2
TXMD = T
TX 12-001HR Estradiol 2mg / Progesterone 200 mg (combination)
vs. Estrace® 2m g + Prometrium® 200 mg (separate tablets)
Parameter
Point Estimate
T/R Ratio
Within Subject
Std. Deviation
Upper 95%
Confidence Bound
Cmax 0.88 0.344 -0.040
AUC0-t 0.93 0.409 -0.089
(1) Semilog plots of mean plasma concentrations over time for Free Estradiol.
Drug Improvement General Benefits Patient Benefits
Receive FDA approved
indication
FDA indication / safety and quality
assurance
Insurance coverage
Safety, quality, and stability
New lower effective doses Reduced blood levels
Better side effect profile
Improved safety
Improved safety profile vs.
non-bioidentical progestin
Reduced breast cancer risk
Improved cardiovascular and lipid
profile
Confidence in treatment regimen
No peanut oil Non-allergenic
Excellent for all patient profiles
No worries about potential
allergies
Combined pill vs. 2 pills
(E+P sold separately today)
Less risk of dosing errors One co-pay
Increased compliance
17
TX 12-001HR Combination Potential Benefits
Note: Potential improvements and benefits, if approved.
Product Progestin
U.S. Sales (est.)
($mm)
Intl Sales
($mm) (4) Company
17β Estradiol + NETA /
Drospirenone
(Activella / FemHRT / Angeliq /
others)
Non-bioidentical $178 (1)(2)
Premarin + MPA
(Prempro / Premphase)
Non-bioidentical 290 (1)(2)
Estradiol + Progesterone
(custom compounded)
Untested
Bioidentical
1,500 (3)
Not FDA approved
Total Oral Combination Sales $1,968 $489
18
FDA Approved Products in Use Lack Innovation
All FDA approved products in use contain non-bioidentical
progestins
Notes: All FDA approved combination products in use contain a non-bioidentical progestin.
(1) Phast Prescription Monthly by Source Healthcare Analytics.
(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
(3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS.
(4) IMS Data
19
New Lower Dose
Progesterone
Phase 3 Trial
Trial: 2 studies; 12 days, 3 cycles
Sites: 10-15 each
Subject: 180
− 3 arms (60 per arm)
Estimated cost: $5-$8 million
RLD = 400 mg
Endpoints
− Withdrawal bleeding and secretory change
20
TX 12-002HR Progesterone—
Proposed Phase 3 Study
2012 2013E 2014E 2015E
Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15
Filed
IND
Pilot PK
Study
Pivotal PK
Studies
File NDA and PDUFA
Two Phase 3 Amenorrhea Studies
12 Days & 3 Cycles
TX12-002HR
Progesterone
File IND Update &
Phase 3 Protocol
Progesterone
Conducted PK studies in accordance with FDA requirements
TXMD 150 mg test dose found to be bioequivalent
to 200 mg Prometrium®
Summary evaluations of baseline-corrected Progesterone results
for a theoretical
150 mg test capsule vs. 200 mg Prometrium® capsule
21
Parameter
Point Estimate
T/R Ratio
Within Subject
Std. Deviation
Upper 95%
Confidence Bound
Cmax 1.03 1.133 -0.747
AUC0-t 0.96 0.891 -0.465
TX 12-002HR Progesterone Candidate
Drug Improvement General Benefits Patient Benefits
New lower effective doses Lower first-pass metabolites
Better side effect profile
Less somnolence
Improved safety
Improved safety profile vs.
non-bioidentical progestin
Reduced breast cancer risk
Improved cardiovascular profile
Improved lipid profile
Confidence in treatment regimen
No peanut oil Non-allergenic
Excellent for all patient profiles
No worries about potential
allergies
22
TX 12-002HR Progesterone—
Potential Benefits
Note: Potential improvements and benefits, if approved.
Product Progestin
U.S. Sales
(est.)
($mm) (1)(2) INTL Sales (3) Company
Generic
Available
Provera®
(medroxyprogesterone
acetate)
Non-
bioidentical
$26 
Aygestin®
(norethindrone acetate)
Non-
bioidentical
45 
Prometrium®
(micronized progesterone)
Bioidentical 247 
Total Oral Progestin Sales $318 $600
23
(1) Phast Prescription Monthly by Source Healthcare Analytics.
(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
(3) IMS Data
Natural Progesterone Dominates
24
Other Programs
Product Compound
U.S. Sales (est.)
($mm) (1)(2) Problems
Premarin
®
Cream
Conjugated equine
vaginal estrogen
$265
Equine source
Non-bioidentical
Messy
Reusable plungers
Vagifem®
Tablets
Estrace
®
Cream
Vaginal estradiol $558
Messy
Reusable plungers
Difficult to use
Continuous-use mechanical device
Total Sales $823
25
(1) Phast Prescription Monthly by Source Healthcare Analytics.
(2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012.
TX 12-004HR Estradiol Product—
Vulvar / Vaginal Atrophy
Phase 3 Trial
Trial: 12 weeks
Sites: 30-40
Subjects: 375-400
− 2 active arms (150 per arm)
− 100 placebo
Endpoints
− Cell change
− Lowering of pH
− Lowering of most bothersome symptoms
26
TX 12-004HR Proposed Estradiol Vaginal
Suppository—Proposed Phase 3 Study
Estradiol
2013E 2014E 2015E 2016E
Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16
Expect to
File
IND
File
NDA
NDA
Approval
Pilot PK
Study
Pivotal PK
Studies
File NDA and PDUFA
Phase 3 Clinical Vulvar & Vaginal Atrophy
TX 12-004HR
17β Estradiol in a
VagiCap
File IND Update &
Phase 3 Protocol
™
27
John
Milligan
President
Julia
Amadio
Chief
Product
Officer
Dan
Cartwright
Chief
Financial
Officer
Dr. Brian
Bernick
Chief
Medical
Officer and
Director
Robert Finizio
Chief Executive Officer
vitaMed HT Corporate
Jason
Spitz
Vice
President,
Marketing
Management Drug Development Team
Proven team with a successful track record of creating shareholder value and
developing some of the most successful products in the HT and birth control space
Experienced Management and
Drug Development Team
Julia Amadio and James Pickar, M.D., F.A.C.O.G.
‒ Led development and launch of Prempro®, Premphase®,
CombiPatch®, Alesse®, and Crinone®, among others
Lisa Rarick, M.D. and Daniel Shames, M.D.
‒ Former division Director of Reproductive and Urologic
Products for FDA CDER
Fred Sancilio, Ph.D.
‒ Former founder and president of AAI and the innovator
of multiple hormone products
Steve Fontana, J.D.
‒ Author of the original estradiol patents
Bill Mulholland, J.D.
‒ Lead patent attorney; previously, IP counsel at Pfizer
Board of Directors and Investors
Tommy
Thompson
Chairman
Former
Sec HHS &
Gov of Wisc
Cooper
Collins
Director
CEO,
Pernix
Mario Family
Partnership
Investor
Ernest Mario
Former CEO
of Glaxo
Jules
Musing
Former Sr.
Executive
Johnson &
Johnson
Nick
Segal
Director
Seavest
Capital
Partners
28
Potential Milestones
2012 2013E 2014E 2015E 2016E
Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16
Filed
IND
Pilot PK
Studies
Pivotal PK
Studies
NDA and PDUFA
Phase 3 Vasomotor and Endometrial Protection Study
Filed
IND
Pilot PK
Study
Pivotal PK
Studies
File NDA and PDUFA
Two Phase 3 Amenorrhea Studies
12 Days & 3 Cycles
File
IND
Expect to
File
IND
File
NDA
NDA
Approval
Pilot PK
Study
Pivotal PK
Studies
File NDA and PDUFA
Phase 3 Clinical Vulvar & Vaginal Atrophy
TX 12-001HR
Combination
17β Estradiol
+
Progesterone
TX12-002HR
Progesterone
TX 12-004HR
17β Estradiol in a
VagiCap
File IND Update &
Phase 3 Protocol
File IND Update &
Phase 3 Protocol
File IND Update &
Phase 3 Protocol
29
Investment Highlights
1 Novel late-stage hormone therapy candidates
2 Clear pivotal trial endpoints / low risk regulatory pathway
3
Compelling, growing market opportunity, especially with recent concerns regarding
compounders
4 Recently completed $50 million equity financing
5 Robust, growing patent estate

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TherapeuticsMD TXMD Slide Show June 2013

  • 1. Jefferies Global Healthcare Conference June 2013 COPYRIGHT 2013 by TherapeuticsMD
  • 2. This presentation includes forward-looking statements covered by the safe harbor provision of the Private Securities Litigation Reform Act of 1995, including predictions, estimates, and other information that might be considered forward-looking. While these forward-looking statements represent TherapeuticsMD, Inc.’s (“TherapeuticsMD,” “we,” “us,” and “our”) current judgment on what the future holds, they are subject to risks and uncertainties, many of which are outside our control, that could cause actual results to differ materially from the results discussed in the forward- looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information, future events, or otherwise. Throughout this presentation, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Form 10-K and our other filings with the Securities and Exchange Commission, for a more complete discussion of these factors and other risks, particularly under the heading “Risk Factors.” A PDF copy of our SEC filings, press releases and financial tables can be viewed and downloaded on the TherapeuticsMD website: www.therapeuticsmd.com/InvestorRelations.aspx. 1 Forward-Looking Statements
  • 4. 3 TXMD Company History Founded in May of 2008 Originally a prenatal vitamin company Recently listed on NYSE MKT under “TXMD” Shares outstanding: approximately 130 million Approximately $40 million in cash; no long-term debt Strong board with blue-chip institutional holders Gov. Tommy Thompson, Jules Musing, Ernest Mario (investor)
  • 5. 2013E 2014E 2015E 2016E U.S. Sales (est.)($mm) (1)(2) Combination: 17β Estradiol + Progesterone $2,000 Oral Progesterone $300 Novel estradiol pipeline product in development 17β Estradiol in VagiCap™ $800 Phase 3 Plan Expect to File NDA and PDUFA 4 Innovative Women’s Healthcare Company Two late-stage 505(b)(2) proposed hormone therapy (“HT”) products targeting a multi-billion dollar U.S. market (1)(2) Bioidentical combination of estradiol + progesterone and lower-dose bioidentical progesterone Set to begin pivotal Phase 3 clinical trials (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Estimates per: Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding; Tom Murry, Executive Director of the Pharmaceutical Compounding Accreditation Board; and Wulf Utian, Consultant on Gynecology and Women¹s Health at The Cleveland Clinic and Executive Director Emeritus and Honorary Founding President of The North American Menopause Society (“NAMS”).
  • 6. 5 History of Hormone Therapy 2002 Women’s Health Initiative (WHI) Study Lower doses = lower side effect profile Estrogen + Progestin (Prempro) arm had a 22% increase in breast cancer vs. Estrogen alone arm Resulting Hormone Prescribing Trends Start with the lowest effective dose Progesterone (bioidentical) popularity over Progestins (non-bioidentical) Bioidentical (exact molecular structure of human Estrogen and Progesterone) sales sky rocket
  • 7. Sales of FDA approved oral combination estrogen + progestin products Compounding pharmacy sales of unapproved estradiol + progesterone 6  Significant demand HT Combination Market Landscape (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS. (4) Dr. Loyd Allen Jr., Editor-in-Chief of the International Journal of Pharmaceutical Compounding, stated the U.S. drug compounding market is $10-$12 billion; and Tom Murry, Executive Director of the Pharmaceutical Compounding Accreditation Board, said HT for post-menopausal women is by far the largest of four primary segments served by the compounding industry. (5) 134 Compounding Pharmacies Survey in 34 States  $1,500 MM (3)(4) $468 MM (1)(2) U.S. Sales (est.) Average Selling Price $46.89(5) Average WAC Price $185.09(3)
  • 8. Side Effect (1) Bioidentical Natural Progesterone Non-Bioidentical Progestins (MPA, NETA, drosperinone) Breast cancer More favorable profile (E3N-EPIC study) Increased risk Cardiovascular More favorable profile (PEPI trial) Increased risk of MI, stroke, VTE Lipid profile More favorable profile (PEPI trial) Less favorable effects on lipid profile (cholesterol, HDL, LDL, triglycerides) Glucose / insulin Improved carbohydrate metabolism (PEPI trial) Deterioration of glucose tolerance or hyperinsulemia or both Sleep / mood Improved sleep efficiency (2) No benefit on sleep properties Quality of life Improvement in symptoms and overall satisfaction with bioidentical progesterone HT compared to MPA regimen (3) 7 (1) Alone or in combination with estrogen. (2) Caufriez, Anne, Rachel Leproult, Mireille L’Hermite-Bale´riau, Myriam Kerkhofs, and Georges Copinschi. "Progesterone Prevents Sleep Disturbances and Modulates GH, TSH, and Melatonin Secretion in Postmenopausal Women." J Clin Endocrinol Metab 96.4 (2011): 614-23. (3) Fitzpatrick, Pace, and Wiita. "Comparison of Regimens Containing Oral Micronized Progesterone or Medroxyprogesterone Acetate on Quality of Life in Postmenopausal Women: A Cross- Sectional Survey." J Womens Health Gend Based Med 9.4 (2000): 381-87. Bioidentical Progesterone vs. Non-Bioidentical Progestin The Market understands the benefits of bioidentical HT
  • 9. 8  Meet PK 505(b)(2) thresholds Novel Drug Design Combination of Estradiol + Progesterone RLD = Reference Listed Drug API = Active Pharmaceutical Ingredient Converted (API) from solid / crystalline to a New Liquid Drug Form Estrace (RLD) is a tablet — 0.5 mg, 1.0 mg, and 2.0 mg Prometrium (RLD) is in suspension — 100 mg and 200 mg New solubilized drug form Achieves FDA requirements of uniformity and stability Improved functional effects of API(s) Enabling new combinations, routes, and dosages
  • 10. 9 Building an Extensive Patent Estate Novel Drug Form Based Approach Solubilized API in combination and stand-alone drug products for HT indications Enabling platform technology for delivery of bioidenticals to variety of dosage forms and routes of administration (softgel oral, suppository, transdermal, etc.) Multi-layered Patent Strategy Novel dosage forms, improved PK profiles (lowest effective dose, increased bioavailability) relative to RLD, reduced side effect profile, and formulation advancements (solvent systems, chemical stability, ratios, ranges, and functional effects)
  • 11. 10 Senate HELP Bill 959 on Compounding New England Compounding Center Response to Meningitis outbreak, killed 50 and made over 700 patients sick Multiple other cases of unsafe drug sales by other compounding pharmacies Senate Bill Highlights (1) Establishes clear FDA oversight funded by compounding pharmacy registration fees “Prohibits compounding of certain drug products, including those identified by regulation as being demonstrably difficult to compound (such as complex dosage forms and biologics), marketed FDA-approved drugs that are not in shortage” (1) http://www.help.senate.gov/imo/media/Compounding_Draft_One_Pager_FINAL.pdf
  • 12. 11 Market Forces Converge External market changing events WHI Proposed legislative changes Internal scientific breakthrough Significant shifts favor TXMD
  • 13. 12 Why Hormone Therapy? HT is projected to be the largest growth segment in the overall women’s health drug market Demographics driving strong growth fundamentals By 2015, nearly half the women in America will be of menopausal age (1) Women will spend more than a third of their life in menopause and post-menopause Very attractive commercial dynamics Segment of the market that lacks innovation Relatively little promotional activity in the space Opportunity to capture market share (1) U.S. Census Bureau.
  • 15. 14 Phase 3 Trial Study: 12 month study with 12 week VMS Sites: ~50 Subjects: 1,550 − 4 active arms (350 per arm) − 1 placebo arm (150) Estimated cost: $20-$25 million Endpoints − Vasomotor: number and severity of hot flashes (4 week and 12 weeks) − Endometrial safety: incidence of endometrial hyperplasia (12 months)  Conduct Phase 3 study TX 12-001HR Combination— Proposed Phase 3 Study  Combination of Estradiol + Progesterone 2012 2013E 2014E 2015E 2016E Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed IND Pilot PK Studies Pivotal PK Studies NDA and PDUFA Phase 3 Vasomotor and Endometrial Protection Study TX 12-001HR Combination 17β Estradiol + Progesterone File IND Update & Phase 3 Protocol
  • 16. n = 62 15 95% Upper Confidence Limit for PK Parameter Prometrium = R1 Prometrium = R2 TXMD = T Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound Cmax 1.16 1.179 -0.785 AUC0-t 1.05 0.956 -0.542 Progesterone Results (1) (1) Semilog plots of mean plasma concentrations over time for Progesterone. TX 12-001HR Estradiol 2 mg / Progesterone 200 mg (combination) vs. Estrace® 2 mg + Prometrium® 200 mg (separate tablets)
  • 17. 1 10 100 0 5 10 15 20 25 30 35 40 45 50 Time (hr) Treatment=R1 Treatment=R2 Treatment=T N=6217β Estradiol Results (1) n = 62 95% Confidence Interval for PK Parameter 16 Estrace = R1 Estrace = R2 TXMD = T TX 12-001HR Estradiol 2mg / Progesterone 200 mg (combination) vs. Estrace® 2m g + Prometrium® 200 mg (separate tablets) Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound Cmax 0.88 0.344 -0.040 AUC0-t 0.93 0.409 -0.089 (1) Semilog plots of mean plasma concentrations over time for Free Estradiol.
  • 18. Drug Improvement General Benefits Patient Benefits Receive FDA approved indication FDA indication / safety and quality assurance Insurance coverage Safety, quality, and stability New lower effective doses Reduced blood levels Better side effect profile Improved safety Improved safety profile vs. non-bioidentical progestin Reduced breast cancer risk Improved cardiovascular and lipid profile Confidence in treatment regimen No peanut oil Non-allergenic Excellent for all patient profiles No worries about potential allergies Combined pill vs. 2 pills (E+P sold separately today) Less risk of dosing errors One co-pay Increased compliance 17 TX 12-001HR Combination Potential Benefits Note: Potential improvements and benefits, if approved.
  • 19. Product Progestin U.S. Sales (est.) ($mm) Intl Sales ($mm) (4) Company 17β Estradiol + NETA / Drospirenone (Activella / FemHRT / Angeliq / others) Non-bioidentical $178 (1)(2) Premarin + MPA (Prempro / Premphase) Non-bioidentical 290 (1)(2) Estradiol + Progesterone (custom compounded) Untested Bioidentical 1,500 (3) Not FDA approved Total Oral Combination Sales $1,968 $489 18 FDA Approved Products in Use Lack Innovation All FDA approved products in use contain non-bioidentical progestins Notes: All FDA approved combination products in use contain a non-bioidentical progestin. (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. (3) Estimate per Wulf Utian, Executive Director Emeritus and Honorary Founding President of NAMS. (4) IMS Data
  • 21. Phase 3 Trial Trial: 2 studies; 12 days, 3 cycles Sites: 10-15 each Subject: 180 − 3 arms (60 per arm) Estimated cost: $5-$8 million RLD = 400 mg Endpoints − Withdrawal bleeding and secretory change 20 TX 12-002HR Progesterone— Proposed Phase 3 Study 2012 2013E 2014E 2015E Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Filed IND Pilot PK Study Pivotal PK Studies File NDA and PDUFA Two Phase 3 Amenorrhea Studies 12 Days & 3 Cycles TX12-002HR Progesterone File IND Update & Phase 3 Protocol Progesterone
  • 22. Conducted PK studies in accordance with FDA requirements TXMD 150 mg test dose found to be bioequivalent to 200 mg Prometrium® Summary evaluations of baseline-corrected Progesterone results for a theoretical 150 mg test capsule vs. 200 mg Prometrium® capsule 21 Parameter Point Estimate T/R Ratio Within Subject Std. Deviation Upper 95% Confidence Bound Cmax 1.03 1.133 -0.747 AUC0-t 0.96 0.891 -0.465 TX 12-002HR Progesterone Candidate
  • 23. Drug Improvement General Benefits Patient Benefits New lower effective doses Lower first-pass metabolites Better side effect profile Less somnolence Improved safety Improved safety profile vs. non-bioidentical progestin Reduced breast cancer risk Improved cardiovascular profile Improved lipid profile Confidence in treatment regimen No peanut oil Non-allergenic Excellent for all patient profiles No worries about potential allergies 22 TX 12-002HR Progesterone— Potential Benefits Note: Potential improvements and benefits, if approved.
  • 24. Product Progestin U.S. Sales (est.) ($mm) (1)(2) INTL Sales (3) Company Generic Available Provera® (medroxyprogesterone acetate) Non- bioidentical $26  Aygestin® (norethindrone acetate) Non- bioidentical 45  Prometrium® (micronized progesterone) Bioidentical 247  Total Oral Progestin Sales $318 $600 23 (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. (3) IMS Data Natural Progesterone Dominates
  • 26. Product Compound U.S. Sales (est.) ($mm) (1)(2) Problems Premarin ® Cream Conjugated equine vaginal estrogen $265 Equine source Non-bioidentical Messy Reusable plungers Vagifem® Tablets Estrace ® Cream Vaginal estradiol $558 Messy Reusable plungers Difficult to use Continuous-use mechanical device Total Sales $823 25 (1) Phast Prescription Monthly by Source Healthcare Analytics. (2) Based on last twelve months sales through June 30, 2012, and estimated sales from July 1 through December 31, 2012. TX 12-004HR Estradiol Product— Vulvar / Vaginal Atrophy
  • 27. Phase 3 Trial Trial: 12 weeks Sites: 30-40 Subjects: 375-400 − 2 active arms (150 per arm) − 100 placebo Endpoints − Cell change − Lowering of pH − Lowering of most bothersome symptoms 26 TX 12-004HR Proposed Estradiol Vaginal Suppository—Proposed Phase 3 Study Estradiol 2013E 2014E 2015E 2016E Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Expect to File IND File NDA NDA Approval Pilot PK Study Pivotal PK Studies File NDA and PDUFA Phase 3 Clinical Vulvar & Vaginal Atrophy TX 12-004HR 17β Estradiol in a VagiCap File IND Update & Phase 3 Protocol ™
  • 28. 27 John Milligan President Julia Amadio Chief Product Officer Dan Cartwright Chief Financial Officer Dr. Brian Bernick Chief Medical Officer and Director Robert Finizio Chief Executive Officer vitaMed HT Corporate Jason Spitz Vice President, Marketing Management Drug Development Team Proven team with a successful track record of creating shareholder value and developing some of the most successful products in the HT and birth control space Experienced Management and Drug Development Team Julia Amadio and James Pickar, M.D., F.A.C.O.G. ‒ Led development and launch of Prempro®, Premphase®, CombiPatch®, Alesse®, and Crinone®, among others Lisa Rarick, M.D. and Daniel Shames, M.D. ‒ Former division Director of Reproductive and Urologic Products for FDA CDER Fred Sancilio, Ph.D. ‒ Former founder and president of AAI and the innovator of multiple hormone products Steve Fontana, J.D. ‒ Author of the original estradiol patents Bill Mulholland, J.D. ‒ Lead patent attorney; previously, IP counsel at Pfizer Board of Directors and Investors Tommy Thompson Chairman Former Sec HHS & Gov of Wisc Cooper Collins Director CEO, Pernix Mario Family Partnership Investor Ernest Mario Former CEO of Glaxo Jules Musing Former Sr. Executive Johnson & Johnson Nick Segal Director Seavest Capital Partners
  • 29. 28 Potential Milestones 2012 2013E 2014E 2015E 2016E Q3 '12 Q4 '12 Q1 '13 Q2 '13 Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15 Q4 '15 Q1 '16 Q2 '16 Q3 '16 Q4 '16 Filed IND Pilot PK Studies Pivotal PK Studies NDA and PDUFA Phase 3 Vasomotor and Endometrial Protection Study Filed IND Pilot PK Study Pivotal PK Studies File NDA and PDUFA Two Phase 3 Amenorrhea Studies 12 Days & 3 Cycles File IND Expect to File IND File NDA NDA Approval Pilot PK Study Pivotal PK Studies File NDA and PDUFA Phase 3 Clinical Vulvar & Vaginal Atrophy TX 12-001HR Combination 17β Estradiol + Progesterone TX12-002HR Progesterone TX 12-004HR 17β Estradiol in a VagiCap File IND Update & Phase 3 Protocol File IND Update & Phase 3 Protocol File IND Update & Phase 3 Protocol
  • 30. 29 Investment Highlights 1 Novel late-stage hormone therapy candidates 2 Clear pivotal trial endpoints / low risk regulatory pathway 3 Compelling, growing market opportunity, especially with recent concerns regarding compounders 4 Recently completed $50 million equity financing 5 Robust, growing patent estate